Application 206045
- Type
- ANDA
- Sponsor
- KENTON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RILUZOLE | RILUZOLE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-775 | Riluzole | riluzole | AvKARE | ANDA | Current |
| 42291-775 | Riluzole | riluzole | AvKARE | ANDA | Current |
| 69076-200 | Riluzole | riluzole | Quinn Pharmaceuticals | ANDA | Current |
| 69076-200 | Riluzole | riluzole | Quinn Pharmaceuticals | ANDA | Current |
| 69076-200 | Riluzole | riluzole | Florida Pharmaceutical Products, LLC. | ANDA | Current |